Ketone body testing

[SMILLER]

Acetest tablets are no longer available from Bayer. After some research, I find that a beta-hydroxybutyrate acid test is a better test anyway for screening for ketoacidosis in diabetics.

What methods are out there to be used for a BHBA?

Thanks, Scott

[LG53]

I have had good luck in the past with the Stanbio reagent. It is a liquid reagent that adapts well to an analyser with open channels (user defined chemistries). At my last job, we used it on a Vitros Fusion, and we are now about to try it with the Dimension XL. There may be other tests out there by now as this really is the way to go for monitoring DKA. I would caution you about the POC test by Abbott. We evaluated that one and it wasn't very accurate in patients with high levels of ketones. I think it was a linearity problem- it would be good for screening, but no diagnostic monitoring.

[Bill]

Acetest tablets are again available. We have received 3 different shipments within past four months.

[SMILLER]

We started using a Beta Hydroxy Butyrate (BHOB) test on our Vitros FS. Works well. Apparently better for detecting ketoacidosis than the Bayer tabs anyway.

Scott

[hvtimkang]

we were told by our purchasing department that acetest is on back order again.we are a small hospital lab and maybe having the stanbio bhba uda on our vitros will not be cost effective for us:cries: what is the test kit name of the bhba test from abbott?Thanks!

[BHB2U]

With 9 out of top 10, 15 of the top 25 and 49 of the top 100 Hospitals in the US running Stanbio Beta-Hydroxybutyrate test to Dx and monitor DKA patients, we have a compelling story to tell. Try us at www.stanbio.com/bhb dedicated web portal with information not only about the condition, and product but also available applications for chemistry platforms and Peer Group Data.

[milesd3]

I know this is an old thread but I thought I'd revive it with a question and a concern.  I recently found out that ketone testing on the K-Check tablet is now moderately complex.  We have been using biorad urine controls for a very long time on the acetest tablet and since we started using the K-Check tablet a year or two ago.  Biorad said they didn't have anything yet for serum/plasma so my question is since there is a matrix effect on the tablet, I'm guessing controls with a similar matrix should be performed with the patient testing...? I called Quest (our reference lab)and they said they couldn't even talk to me about the question.  I spoke with a few other labs and no one is even aware that a change has been made.  Years ago we got ourselves in a little trouble with JCAHO over qualitative hcG testing and only using urine controls so I'm trying to not have that problem with ketone testing. Does anyone know of a control available for serum/ketone testing?  The insert says you can make a control with 50uL acetone and 40mL DI water however that wouldn't be the correct matrix. 

[SMILLER]

You might be safe with what the insert recommends for a positive control, as long as it also states that the test can be used for serum.  I would call the company to ask for advice--they may know of a serum control supplier.

A few years ago, when the Acetest supply ran dry, we switched to an automated B-hydroxybuterate test, which is both more specific and sensitive and easier to run than the old titre-an-acetest-tablet.  Our platform is an Ortho Vitros F.S.

Scott

[milesd3]

21 hours ago, SMILLER said:

You might be safe with what the insert recommends for a positive control, as long as it also states that the test can be used for serum.  I would call the company to ask for advice--they may know of a serum control supplier.

A few years ago, when the Acetest supply ran dry, we switched to an automated B-hydroxybuterate test, which is both more specific and sensitive and easier to run than the old titre-an-acetest-tablet.  Our platform is an Ortho Vitros F.S.

Scott

Thanks Scott, I called the company 1st for advice and he referred me to BioRad and their "Volatiles" control.  I called BioRad and they said their two level control was designed for a quantitative methodology and both levels have Ketones in them but she also stated that when using them with the tablets resulted in a speckled pattern and not the steady purple one would expect to see with a positive patient thus FDA would not verify their use for qualitative testing.  She did tell me they were trying to develop QC for the K-Test though but didn't have a time frame for when it may be available.  I think they are still talking to the manufacture at this point.  Here is the section regarding QC its rather vague (not as vague as the answer I received from JCAHO when I inquired though..):

Quality Control: Use known positive and negative controls as recommended by your Institutional guidelines. This could vary from daily to weekly quality control. At least a positive and negative control must be run each time a new bottle of K –Check is opened. A positive control can be prepared by diluting 50 microlitres (one drop) of acetone to 40 ml of distilled water. The preparation should be comparable to “small”on the color chart.

We don't do allot of ketone testing at our small rural facility and I'd say that almost all the tests are from the ER   I'll check with Siemens to see if they offer  B-hydroxybuterate test but at $24 a bottle of 100 tablets and the Dr's used to the semi quantative (small, moderate, large) result from the tablet, I think it would be a hard sell to our administration.  I thought about trying the homemade control only use serum instead of DI water but I'm not sure how to validate it. 

[SMILLER]

Silly regulators! Vague when you need guidance and picky when they do a survey!

Since decent third-party QC material is unavailable, and the kit is designed to test serum/plasma, and the insert gives you specific instructions on how to make QC, I would think you would be safe with doing that, in spite of whatever you think about the matrix issue.  

Anyway, I would think that you could correlate your own "matrix-appropriate" mixtures with what happens with what the manufacturer suggests for QC, document it, and then that would be OK to use for your own QC material.

Scott